Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02969850
Eligibility Criteria:
Inclusion Criteria:
1. Ambulatory women older than 60 years of age. Women who are ambulatory with an assistive device such as cane or walker may be included. LMP must be \> 5 years ago.
2. Self declared as white.
3. 20 nmol/L \< Serum 25(OH)D level \< 65 nmol/L.
4. Willingness to take study drug and participate for 6 months in the trial.
5. Willingness to refrain from the use of self-administered Vitamin D and Calcium supplements during the trial.
Exclusion Criteria:
1. Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
2. BMD total hip below -2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
3. Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
4. Treatment with HRT, SERMs, calcitonin, PTH, strontium ranelate, androgens, bisphosphonates, Denosumab or anabolic steroids during 6 months prior to entry.
5. Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
6. Mini-Mental State Exam score below 21
7. Hypercalcemia (serum calcium \> 10.6 mg/dl) or history of primary hyperparathyroidism.
8. History of hypercalciuria, kidney stones, or 24hr urine calcium \>261 mg/day on screening.
9. History of chronic liver disease, chronic renal insufficiency (GFR\<30), Parkinson's, metabolic bone disease (Hyperparathyroidism, Hypoparathyroidism, Paget's disease, Fibrous osteodystrophy, Rickets, Osteomalacia, Osteosclerosis), hematologic tumors, rheumatologic disease requiring steroids, conditions that influence vitamin D absorption like celiac disease and irritable bowel disease, malabsorption or new diagnosis or active treatment of cancer 12 months prior to inclusion.
10. Use of medications that influence bone metabolism (e.g. anticonvulsants).
11. Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of uncontrolled hypertension, uncontrolled diabetes, hypercalciuria, nephrolithiasis and active sarcoidosis or tuberculosis will also be excluded.
12. Participation in another investigational trial 30 days prior to screening.
13. Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
14. Bilateral hip replacement.
15. Currently smoking more than 10 cigarettes daily.
16. Currently consuming more than 2 units of alcohol daily. (One unit is equivalent to a standard glass of beer (285ml), a single measure of spirits (30ml), a medium-sized glass of wine (120ml), or 1 measure of an aperitif (60ml)
17. Unable to perform DXA due to excessive body girth/width. Body width on DXA \> 25 cm.
18. Patients who are deemed unsafe to perform muscular function testing as evaluated by the investigator.
19. Class III obesity.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT02969850
Study Brief:
Protocol Section:
NCT02969850